BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARIETEX UGYTEX PP POSTERIOR KIT X1

    MDR report key: 3000991 · Received February 27, 2013

    Report

    Report Number
    9615742-2013-00127
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    July 25, 2006
    Report Date
    January 30, 2013
    Manufacturer
    SOFRADIM PRODUCTION
    Product Code
    FTL
    PMA / PMN Number
    K051503
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION FROM THE IMPORTER REPORT: (B)(6) 2013, AVAULTA POSTERIOR BIOSYNETHIC SUPPORT SYSTEM, CATALOG#: 486020, (B)(6).

    Description of Event or Problem · 1

    PROCEDURE TYPE: UROGYNECOLOGICAL. ACCORDING TO THE REPORTER: THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. PRODUCT WAS USED FOR THERAPEUTIC TREATMENT. CALDERA MEDICAL - T-SLING WAS REPORTED TO BE USED/IMPLANTED DURING THIS PROCEDURE. THE PATIENT'S ATTORNEY ALLEGED A DEFICIENCY AGAINST THE DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83557 PARIETEX UGYTEX PP POSTERIOR KIT X1 AVAULTA POSTERIOR SYSTEM FTL SOFRADIM PRODUCTION NA PFG00404

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R CALDERA MEDICAL-T-SLING